NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as MERCK SHARP DOHME. It is marketed under 1 brand name, including BELSOMRA. Available in 4 different strengths, such as 5MG, 10MG, 15MG and others, and administered through 1 route including TABLET;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"90823","ingredient":"SUVOREXANT","trade_name":"BELSOMRA","family_id":"d308d9181f8c4686a4a3","publication_number":"US7951797B2","cleaned_patent_number":"7951797","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-20","publication_date":"2011-05-31","legal_status":"Granted"} | US7951797B2 Molecular Formulation | 31 May, 2011 | Granted | 20 Nov, 2029 | |
| {"application_id":"90875","ingredient":"SUVOREXANT","trade_name":"BELSOMRA","family_id":"d59f699d86984ec1afa0","publication_number":"US10098892B2","cleaned_patent_number":"10098892","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-29","publication_date":"2018-10-16","legal_status":"Granted"} | US10098892B2 Formulation | 16 Oct, 2018 | Granted | 29 May, 2033 | |
| {"application_id":"90889","ingredient":"SUVOREXANT","trade_name":"BELSOMRA","family_id":"d59f699d86984ec1afa0","publication_number":"US11980623B2","cleaned_patent_number":"11980623","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-29","publication_date":"2024-05-14","legal_status":"Granted"} | US11980623B2 Formulation | 14 May, 2024 | Granted | 29 May, 2033 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.